US panel backs more peptides for compounding despite safety concerns

A United States review panel recommended loosening restrictions on all but one of seven peptides considered during a two-day meeting, despite objections from medical experts who said the substances are not well studied enough for broad access.

The advisory committee, assembled to advise the US Food and Drug Administration, considered whether to add the peptides to the US compounding list. The list allows compounding facilities to use certain ingredients when preparing custom medicines for patients with specific prescriptions.

On Friday, the panel backed semax and epitalon. Wellness clinics promote semax for conditions including depression and anxiety. Epitalon is promoted as a substance that can prevent aging and help with insomnia.

The panel narrowly voted against adding emideltide. The substance had been considered for insomnia, narcolepsy and opioid withdrawal, and has been marketed with other claims including stress, pain and cancer. David Pope, chief pharmacy officer for the medical technology company Xifin Pharmacy Solutions, cast a deciding no vote after backing all the previous peptides, citing potentially dangerous downstream consequences.

Those decisions followed Thursday recommendations to add BPC-157, KPV, TB-500 and MOT-c to the list. Physicians and public health advocates warned that the safety and effectiveness of the substances are far from proven.

The recommendations are not binding, but the FDA has historically given such panel advice significant weight. The positive votes also went against agency career scientists who had urged continued restrictions because of limited data and safety concerns.

FDA staffer Russell Wesdyk said in opening remarks Friday that many public commentators and committee members had noted significant quality problems with the substances, as well as issues with common names that could make it harder to identify what they contain. He said he appreciated calls for quality guardrails, but warned that the bulks list does not give the agency the regulatory authority to put those guardrails in place.

Peptides are short chains of amino acids, the building blocks of proteins. They occur naturally in the body, but synthetic peptides have become increasingly popular in the wellness industry. Supporters make broad claims about benefits including skin appearance, muscle growth, brain health and wound healing. The report said there is scant to no clinical evidence supporting such promises, and doctors have warned that endorsing poorly understood substances could steer patients away from evidence-backed treatments.

Medical experts accused President Donald Trump's health chief Robert F. Kennedy Jr. of filling the FDA advisory committee with people who have strong ties to the peptide industry, given his personal interest in and use of the products.

The peptides under review were among substances restricted from compounding during former president Joe Biden's administration, notably because of a lack of human clinical trial data. The report said the substances remain available online from chemical suppliers for lab use.